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The µTASWako AFP-L3 Immunological Test System is an in vitro device that consists of reagents used with the uTASWako i30 Immunoanalyzer to quantitatively measure, by immunochemical techniques, AFP-L3% in human serum. The device is intended for in vitro diagnostic use as an aid in the risk assessment of patients with chronic liver disease for development of hepatocellular carcinoma (HCC) in conjunction with other laboratory findings, imaging studies and clinical assessment. Patients with elevated AFP-L3% values (≥ 10%) have been shown to be associated with an increase in the risk of developing HCC within the next 21 months and should be more intensely evaluated for evidence of HCC according to the existing HCC practice guidelines in oncology. The uTASWako DCP Immunological Test System is an in vitro device that consists of reagents used with the µTASWako i30 Immunoanalyzer to quantitatively measure, by immunochemical techniques, DCP in human serum. The device is intended for in vitro diagnostic use as an aid in the risk assessment of patients with chronic liver disease for development of hepatocellular carcinoma (HCC) in conjunction with other laboratory findings, imaging studies, and clinical assessment. The µTASWako i30 Immunoanalyzer is an in vitro diagnostic automated instrument intended for use to quantitatively measure analytes in clinical chemistry by immunochemical techniques. The uTASWako i30 Immunoanalyzer is indicated for use by healthcare professionals. It is intended for assays cleared or approved for use on this instrument. The Wako uTASWako AFP-L3 Calibrator Set is designed to be used with the Wako µTASWako AFP-L3 Immunological Test System for the quantitative determination of AFP-L3% in human serum. The Wako µTASWako AFP-L3 Control L is designed to be used as quality control material for the quantitative determination of AFP-L3% in human serum using the Wako µTASWako AFP-L3 Immunological Test System. The Wako uTASWako AFP-L3 Control H is designed to be used as quality control material for the quantitative determination of AFP-L3% in human serum using the Wako uTASWako AFP-L3 Immunological Test System. The Wako µTASWako DCP Calibrator Set is designed to be used with the Wako uTASWako DCP Immunological Test System for the quantitative determination of DCP in human serum. The Wako µTASWako DCP Control L is designed to be used as a quality control material for the quantitative determination of DCP in human serum using the Wako µTASWako DCP Immunological Test System. The Wako µTASWako DCP Control H is designed to be used as a quality control material for the quantitative determination of DCP in human serum using the Wako uTASWako DCP Immunological Test System.

The µTASWako i30 Immunoanalyzer System is a fully automated immunoassay system that can perform assays of the uTASWako AFP-L3 and µTASWako DCP Immunological Test Systems. This system automatically conducts sampling, mixing, separation, and fluorescence detection on a microfluidic chip to achieve high sensitivity and accuracy. The instrument contains an automated liquid dispenser, temperature controlled reagent container, chip station, analysis compartment, and sample rack station. The outside panel has a printer and a touch panel with a menu to order measurements and to check the availability for reagent, chip, wash solution, and pure water. A chip is used for each test and is disposable. The instrument is designed to automatically and constantly monitor the reagents, chips, dispensing system and the measurement process so that measurement results are not given when an error occurs. The system is comprised of the following products: uTASWako i30 uTASWako AFP-L3, Calibrator Set, Control L and Control H uTASWako DCP, Calibrator Set, Control L and Control H Instrument and assay accessories as per labeling

The APOLOWAKO T-CHO is for the quantitative determination on the APOLOWAKO analyzer of total cholesterol in whole blood. The APOLOWAKO HDL-C is for the quantitative determination on the APOLOWAKO analyzer of HDL cholesterol in whole blood. The APOLOWAKO TG is for the quantitative determination on the APOLOWAKO analyzer of triglycerides in whole blood. In conjunction with the above values, the APOLOWAKO analyzer also calculates LDL cholesterol for triglyceride values up to 400 mg/dL and T-CHO/HDL-C ratio. APOLOWAKO Analyzer is a discrete photometric chemistry analyzer for clinical use in both central laboratories and in point of care sites. The device is intended to duplicate manual analytical procedures by automatically performing various steps such as pipetting, mixing and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes of clinical interest in whole blood samples. The measurements of total cholesterol, HDL cholesterol, triglycerides, and LDL cholesterol (by calculation for triglyceride values up to 400 mg/dL) when used in conjunction with other biochemical markers and coronary risk factors, is useful in the prediction of CHD/CVD risk and the assessment of CHD/CVD severity.

The APOLOWAKO analyzer is a fully-integrated POC test system that can perform up to six analytical tests per individual sample. The analyzer automatically separates plasma from whole blood for testing. Once the plasma has been separated, it is transferred to a cell on a measurement disk where the chemical reactions take place. The analyzer uses liquid reagents which are packaged into kits. Each kit contains 2 reagent units. Each unit is composed of two enzyme color reagents and a lyophilized calibrator. All of the reagents have a reagent information tag applied to the back of each bottle which controls the reagent parameters and conditions such as, calibration, reagent quantity, shelf-life, and lot number. The instrument contains an automated liquid dispenser, temperature controlled reagent carrousel, analysis compartment, and sample holder. The instrument is designed to automatically and constantly monitor the reagents, dispensing system, measurement disk, and measurement process to ensure that no erroneous results are shown. The APOLOWAKO's lipid panel will include, total cholesterol, HDL cholesterol, LDL cholesterol (by calculation), and triglycerides in tubed venous whole blood. The test system is designed for professional use and consists of a small table top instrument (31 cm wide x 47.5 cm high x 56 cm deep, weight: 25 kg).

The APOLOWAKO HbA1c and APOLOWAKO Glucose are for the quantitative determination on the APOLOWAKO analyzer of hemoglobin A1c (HbA1c) % and glucose in whole blood samples. HbA1c- Measurement of % HbA1c is used to monitor long-term glucose control in individuals with diabetes mellitus. Glucose- Measurement of glucose is used in the diagnosis and treatment of carbohydrate metabolism disorders, including diabetes mellitus, neonatal hypoglycemia and idiopathic hypoglycemia and pancreatic islet cell carcinoma.

The APOLOWAKO analyzer is a fully-integrated POC test system that can perform up to six analytical tests per individual sample. For the HbA Ic test, whole blood, and not plasma, is used. For all other tests, the analyzer automatically separates plasma from whole blood for testing. Once the plasma has been separated, it is transferred to a cell on a measurement disk where the chemical reactions take place. The analyzer uses liquid reagents which are packaged into kits. Each kit contains 2 reagent units. Each unit is composed of two reagents and a calibrator. All of the reagents have a reagent information tag applied to the back of each bottle which controls the reagent parameters and conditions such as, calibration, reagent quantity, shelf-life, and lot number. The instrument contains an automated liquid dispenser, temperature controlled reagent carrousel, analysis compartment, and sample holder. The instrument is designed to automatically and constantly monitor the reagents, dispensing system, measurement disk, and measurement process to ensure that no erroneous results arc shown. The APOLOWAKO HbA1c and APOLOWAKO Glucose include hemoglobin A1c and glucose test reagents. The test system is designed for professional use and consists of a small table top instrument (31 cm wide x 47.5 cm high x 56 cm deep, weight: 25 kg).